If the site or lesion has previously been irradiated, enter "Y" for Yes, otherwise enter "N" for No.

Use pick list.

Measurable / Non-Measurable(m)

Enter "M", for measurable, and "N" for non-measurable, as defined in the protocol.

Use pick list.

Target / Non-Target(m)

Enter "Target" for target lesions that will be assessed for response (e.g. using the RECIST response criteria). Enter "NonTarget" for non target lesions.

Note: Only applicable for studies that use RECIST criteria. It applies to the first time the lesion is detected. It should not be changed based on the subsequent evaluations. For CTMS studies, ‘Target’ will be submitted as ‘Y’, ‘NonTarget’ will be submitted as ‘N’.

Validations

Extent of Disease Lesion Number should be unique in the description section (top repeating group).

Extent of Disease eCRF - Lesions Measurements

Field Name

Description / Instructions

Format

Lesion #(m)

Select a lesion number from the pick list.

Note: This lesion number must appear in the description section (top repeating group).

Use pick list.

Course #(d)

Indicates the course number that this lesion evaluation was done in as derived from the course initiation start date.

5 digits

Day in Course(d)

Indicates the day since the beginning of course that this lesion evaluation was done as derived from the course initiation start date.

5 digits

Evaluation Date(m)

Enter the date of the evaluation (i.e.: date of CT scan). Do not enter the date of the report or when the results were received.

DD-MMM-YYYY

How Measured(m)

Select how the lesion measurement was determined. The same method should be used to measure a specific lesion throughout the study. For example, if the measurements were determined by a chest x-ray, enter CXR.

Use pick list.

First Longest Measurement

Enter the longest lesion measurement in centimeters.

Note: for studies that use RECIST criteria, it should always measure the longest diameter of the lesion even if the actual axis is different from the one used to measure the lesion initially.

6 digits and 2 decimals

Second Longest Measurement

Enter the second longest lesion measurement in centimeters.

Note: not applicable for studies that use RECIST criteria.

6 digits and 2 decimals

Third Longest Measurement

Enter the third longest lesion measurement in centimeters.

Note: not applicable for studies that use RECIST criteria.

6 digits and 2 decimals

Product

Enter the tumor product which is the multiplication of the First and Second Longest Measurements.

8 digits and 2 decimals

Total Tumor Volume

Enter the total tumor volume which is the multiplication of all three measurements.

8 digits and 2 decimals

Evaluation #(m)

Number each evaluation sequentially for each lesion. Use 0 for the baseline evaluation, 1 for the first evaluation, 2 for the second evaluation, etc.

Note: this is the number of the set of scans done after the baseline. For example, if a new lesion was found on the third set of scans that occurred at the end of the course 4, the evaluation number should be 3.

2 digits

Evaluation Code

Select the status of non-measurable lesions at the time of each evaluation. B - Baseline (use for the initial lesion evaluation that was when the treatment started.) D - Decreasing I - Increasing N - New (use for lesions that appear after treatment has started.) R - Resolved S - Stable X - Not ExaminedV - Not Evaluable